Current Report Filing (8-k)
21 February 2017 - 11:33PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 21, 2017
CIDARA THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-36912
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46-1537286
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(State of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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6310 Nancy Ridge Drive, Suite 101
San Diego, California 92121
(Address of principal executive offices, including zip code)
Registrants telephone number, including area code: (858) 752-6170
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 7.01
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Regulation FD Disclosure
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On February 21, 2017, Cidara Therapeutics, Inc. (the Company)
issued a press release relating to the results of its Phase 2 clinical trial of CD101 topical, called the RADIANT study. A copy of the press release is attached as Exhibit 99.1 to this report.
The information contained in this Item 7.01 and in Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed filed for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
On February 21, 2017, the Company reported results from its Phase 2 clinical trial of
CD101 topical, called the RADIANT study, which was designed to evaluate gel and ointment topical formulations of CD101 in women with moderate-to-severe acute vulvovaginal candidiasis (VVC).
The RADIANT study was a multicenter, randomized, open-label, active-controlled, dose-ranging trial that enrolled 125 patients into three treatment cohorts. In
the first cohort, 50 patients were treated with CD101 gel; a second cohort of 50 patients was treated with CD101 ointment. The third cohort comprised 25 patients treated with oral fluconazole.
The study found that while the gel and ointment topical formulations of CD101 were well tolerated, both formulations were similar in efficacy to each other
but lower in clinical and mycological cure rates compared to oral fluconazole. As a result, the Company has discontinued the CD101 topical development program for VVC.
Item 9.01.
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Financial Statements and Exhibits
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(d)
Exhibits
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Exhibit
No.
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Description
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99.1
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Press Release, dated February 21, 2017.
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1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Dated: February 21, 2017
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IGNYTA, INC.
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By:
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/s/ Jeffrey Stein, Ph.D.
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Name:
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Jeffrey Stein, Ph.D.
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Title:
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President and Chief Executive Officer
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2
EXHIBIT INDEX
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Exhibit
No.
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Description
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99.1
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Press Release, dated February 21, 2017.
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3
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